INTRODUCTION

This general information chapter provides a high-level description of principles for immunological test methods (ITMs) that can be used in specified monograph tests, along with information and approaches to analytical development and validation for ITMs. The scope of this chapter is to provide general information that is applicable to all ITMs. The chapter provides a foundation for specific chapters about different types of ITMs, e.g., Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (ELISA) 〈1103〉, Immunological Test Methods—Immunoblot Analysis 〈1104〉 , and Immunological Test Methods—Surface Plasmon Resonance 〈1105〉. This suite of general information chapters is related to the bioassay general information chapters. Use of ITMs for process monitoring, diagnosis, and evaluation of clinical response, assessment of pharmacokinetics/pharmacodynamics/absorption, distribution, metabolism, and excretion (PK/PD/ADME), and other product characterization (nonrelease testing) is outside the scope of this chapter.